Education and debate

United Kingdom research governance strategy

BMJ 2003; 327 doi: 10.1136/bmj.327.7414.553 (Published 4 September 2003)
Cite this as: BMJ 2003;327:553

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  1. Susan Kerrison, assistant director (research governance) (susan.kerrison@uclh.nhs.uk)1,
  2. Nick McNally, assistant director of research and development1,
  3. Allyson M Pollock, director of research and development1
  1. 1University College London Hospitals NHS Trust, London NW1 2LT
  1. Correspondence to: S Kerrison

    The new research governance strategy marks a radical overhaul of the arrangements for medical research in the NHS and academic institutions with far reaching implications for all those taking part in research. The days of registrars and consultants singlehandedly doing research projects are over

    As part of the reforms to NHS research and development strategy announced in 2000, the Department of Health published a research governance strategy for England.1 The basic framework governing research in England had remained unchanged since the 1960s. It is based on measures introduced after the second world war to protect research subjects, such as international convention law,2 international codes of conduct for the medical profession,3 and legal regulation of the pharmaceutical industry. However, the introduction of greater commercial interests into the NHS through research networks involving both public and private interests challenge these protective arrangements. We consider whether the new Research Governance Framework for Health and Social Care1 and the new arrangements for research ethics committees will provide counterbalance to these interests.

    Commercial potential

    In our previous paper we discussed the many partnerships and networks springing up with the commercial sector, the lack of clear accountability arrangements, and the potential for conflicts of interest introduced by the reforms of NHS research and development.4 The involvement of commercial interests was also promoted in the Health and Social Care Act 2001. This encourages NHS institutions to exploit the intellectual property derived from research on patient data and tissues for commercial gain. The head of research for GlaxoSmithKline described the NHS as one of the most underexploited resources of genetic data and tissue in the world,5 which illustrates the large potential for conflicts of interest. The risks posed by maximising the economic potential of research on human subjects have been partly ameliorated by enhanced …

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